Annovis Bio reported fiscal year 2025 financial results and corporate updates highlighting progress in the clinical development of its investigational therapy buntanetap for neurodegenerative diseases, according to the company. The Phase 3 clinical-stage biotechnology firm said the year marked a milestone with the launch of a pivotal Phase 3 trial evaluating buntanetap in early Alzheimer’s disease. As of March 2026, approximately 65 percent of the targeted participants had been enrolled across 83 clinical sites in the United States.
According to the company, the study is designed to evaluate buntanetap over an 18-month period, assessing both symptomatic effects at six months and potential disease-modifying outcomes over the full study duration. The company also reported biomarker findings from earlier studies indicating reductions in markers linked to neurodegeneration, neuroinflammation and toxic protein accumulation. In February 2026, a data and safety monitoring board recommended continuing the Phase 3 trial without modifications following a safety review at the six-month milestone.
In Parkinson’s disease, Annovis launched an open-label extension study in early 2026 to evaluate the long-term safety and tolerability of buntanetap for up to 36 months. The company also reported discussions with the U.S. Food and Drug Administration regarding a potential study in Parkinson’s disease dementia following clinical findings that showed cognitive improvement in certain patient groups treated with the therapy.
Financially, research and development expenses increased to $25.2 million in 2025 compared with $20.0 million in 2024, reflecting expanded clinical trial activity. General and administrative expenses decreased to $4.5 million from $6.7 million in the previous year. Annovis reported a net loss of $1.40 per share for 2025. Cash and cash equivalents totaled $19.5 million at the end of the year, and the company said its current resources are expected to fund operations into the third quarter of 2026.
Annovis develops therapies targeting the production of neurotoxic proteins involved in conditions such as Alzheimer’s disease and Parkinson’s disease, with buntanetap designed as a once-daily oral treatment that addresses multiple pathological pathways linked to neurodegeneration.
